Our Regulatory Affairs team provides critical regulatory guidance at every step of the product development process, from Marketing Authorisation Application to full product life-cycle:

• Regulatory strategy for medicinal products, medical devices, food supplements, cosmetics and food.

• Product Life-cycle management support:
  • Marketing Authorisation Applications, Variations, Notifications, Renewals, other European procedures, etc.
  • Medical and Scientific Writing
  • CMC regulatory strategy
  • eCTD compilation and submission support
  • Readability Testing
  • Global Labelling management
  • Update of Medical Device TechFiles according to the requirements of MDR
• Pharmacovigilance consulting services:
  • SDEA development and maintenance
  • PhV systems management
  • Services of EU QPPV and/or Deputy QPPV
  • EudraVigilance and XEVMPD support
  • Signal and Benefit/Risk management
  • Third party Pharmacovigilance audits
  • Pharmacovigilance trainings
  • ICSR/Cases Management
  • CAPA Management
  • SOP writing and maintenance
  • Vigilance of medical devices

Portfolio of medical devices (in line with current MDR):

• glycerine suppositories
• water-based lubricant gels
• silicone-based lubricant gels
• lubricant gel with hyaluronic acid
• vaginal gel with hyaluronic acid
• vaginal suppositories with hyaluronic acid
• nasal sprays with aloe vera or magnesium
• lice lotion
• hard-boiled sugar lozenges
• hard-boiled sugar-free lozenges
• oral sprays